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The Acrylic Herbst Appliance is intended for the reduction of night time snoring and mild to moderate obstructive sleep appea (OSA) in adults 18 years of age or older.

When a DentiTrac® micro-recorder is embeded into the Acrylic Herbst Appliance, the micro-recorder is intended to measure patient compliance to oral device/appliance therapy in combination with the DentiTrac® System.

The Acrylic Herbst Appliance with Micro-Recorder is comprised of upper and lower customized acrylic splints which are connected bilaterally via a telescoping Herbst mechanism for the treatment of mild to moderate sleep apnea. The micro-recorder is embedded within the appliance. The device aims to improve the patient's air exchange thereby reduce snoring and apnea by increasing the pharyngeal space through anterior repositioning of the mandible. The micro-recorder permits a patient's compliance to prescribed oral therapy to be monitored. The patient contacting portions of the appliance are comprised of medical grade polymethylmethacrylate (acrylic splints) and) which are connected bilaterally via a stainless steel (Herbst) mechanism.

The provided document is a 510(k) summary for a medical device (Acrylic Herbst Appliance with Micro-Recorder) seeking FDA clearance. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study to prove they are met in the way a clinical trial for a novel AI device would.

Here's an analysis based on the information provided, noting what is explicitly stated and what is not applicable or not detailed in this type of submission:

1. Table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

• Not Applicable. This submission is for a physical medical device (intraoral appliance), not an AI/software device. The "test set" for performance was material testing, not patient data in the typical sense of AI evaluation.
• The material performance data appears to be from in-vitro laboratory testing, not specific patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. This information is irrelevant for a physical device where "ground truth" relates to material properties validated by standardized tests.

4. Adjudication method for the test set

• Not Applicable. No human adjudication of patient data for 'ground truth' was performed or described in this type of submission. Material testing results are objective measurements against standards.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Applicable. This is not an AI device. No MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable. This is not an AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The "ground truth" for this device's performance relies on:
  • Material Standards (ISO): For mechanical and thermal properties.
  • Predicate Device Equivalence: The primary "ground truth" for the overall device's safety and effectiveness is its substantial equivalence to previously cleared predicate devices, meaning that if the predicate was safe and effective, and this device is sufficiently similar, then it is also considered safe and effective for its stated use.
  • Risk Analysis: Per the Class II Special Controls Guidance Document to identify and mitigate risks.

8. The sample size for the training set

• Not Applicable. This is not an AI device.

9. How the ground truth for the training set was established

• Not Applicable. This is not an AI device.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets acceptance criteria, as described in this 510(k) summary, is not a clinical trial or an AI performance study, but rather a demonstration of substantial equivalence to legally marketed predicate devices.

The key "studies" presented are:

• Material Performance Testing: The device's materials were subjected to mechanical (Tensile strength, Elongation at tear, E-modulus, Flexion strength, Impaction strength, Rockwell hardness) and thermal (Vicat softening point, Thermoform resistance) performance tests against ISO standards. The results were found "satisfactory" because the identical material is used for both the subject and predicate devices, implying that the material properties are equivalent and thus acceptable.
• Biocompatibility Justification: No additional biocompatibility testing was supplied as the materials and fabrication processes are identical to the predicate device, which had already established biocompatibility.
• Comparative Analysis of Technological Characteristics: A detailed comparison table ([pages 5-6]) highlights the similarities in intended use, target population, prescription status, basic design, adjustability, and manufacturing methods between the proposed device and two predicate devices (SomnoDent® with Micro-Recorder K150369 and Acrylic Herbst Appliance K113126). The "differences" (e.g., adjustment mechanism, materials for the micro-recorder variant, adjustable range) were deemed not to raise new questions regarding safety or effectiveness.
• Risk Analysis: A risk analysis was performed per FDA guidance for intraoral devices for snoring and OSA, and identified risks were mitigated through the use of biocompatible materials (identical to predicate) and appropriate labeling.

In essence, the "study" is a regulatory comparison and material characterization, establishing that the new device is fundamentally the same as already cleared devices, and therefore does not require new clinical data to prove its safety and effectiveness. Clinical testing of the subject device was explicitly stated as not used in support of clearance.

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